[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tr1X, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":133},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,57,89],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":34,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100629666","phase-1-treatment-of-participants-with-primary-or-secondary-progressive-multiple-sclerosis-100629666",false,"NCT07477639","Treatment of Participants With Primary or Secondary Progressive Multiple Sclerosis","A Phase 1\u002F2a, Open-Label, Dose-Escalation Study to Evaluate the Safety and Preliminary Efficacy of TRX319 in Subjects With Primary or Secondary Progressive Multiple Sclerosis","IMPACT-MS","Inclusion Criteria:\n\n1. Clinical diagnosis of MS with evidence of PPMS or SPMS according to 2025 McDonald criteria.\n2. Expanded Disability Status Scale (EDSS) range ≥ 2.5 to ≤ 6.5.\n3. Evidence of clinical disability progression within 2 years prior to enrollment.\n4. Documented presence of CSF-restricted OCBs and\u002For elevated IgG index and\u002For κ free light chain.\n5. Males and females ≥ 18 and ≤ 65 years of age at time of consent.\n6. Evidence of adequate organ function\n7. Women of child bearing potential have a negative pregnancy test at screening.\n8. Contraceptive use by all participants while on study.\n9. Participants must be able to understand, consent, and be willing and able to complete all specified procedures and visits.\n10. Positive varicella zoster virus titer. Participants who test seronegative for varicella zoster virus IgG antibodies need to complete vaccination ≥ 4 weeks prior to TRX319 infusion.\n11. Participants must be willing to refrain from donating blood for 1 year after TRX319 infusion.\n\nExclusion Criteria:\n\n1. MS clinical stability on disease modifying therapy.\n2. Clinical relapse of MS in the 1 year prior to study entry.\n3. Diseases other than MS to explain the first demyelinating event, including aquaporin 4 IgG or myelin oligodendrocyte glycoprotein-IgG seropositivity.\n4. Prior treatment with CAR-T or gene therapy product directed at any target.\n5. Prior treatment with mitoxantrone, cladribine (or other chemotherapies), or alemtuzumab within 2 years prior to TRX319 dose.\n6. Prior treatment with CD20-depleting antibodies within 3 months and prior treatment with Bruton's tyrosine kinase inhibitor (BTKi) and sphingosine 1 phosphate (S1P) modulators within 1 month of TRX319 dose.\n7. Plan to or have received live, attenuated vaccines less than 4 weeks (28 days) prior to TRX319 infusion, and other vaccines less than 2 weeks (14 days) prior to TRX319 infusion.\n8. Serologic status reflecting active hepatitis B or C infection.\n9. Positive serology for human immunodeficiency virus (HIV).\n10. History of progressive multifocal leukoencephalopathy.\n11. Untreated active, or active with documented completed treatment but without a negative chest X-ray that shows no evidence of active tuberculosis, or latent tuberculosis.\n12. Primary immunodeficiency as defined by a known genetic disorder.\n13. History of splenectomy.\n14. Impaired cardiac function or clinically significant cardiac disease.\n15. Previous or concurrent malignancy.\n16. Prior organ transplant, or allogeneic hematopoietic stem cell transplantation or recipient of peripheral blood products \\\u003C 3 years prior to TRX319 infusion.\n17. Major surgery within 4 weeks prior or planned within 4 weeks after TRX319 administration.\n18. History of any other neurologic disorder or medical condition the Investigator considers would increase the risk for the participant, including seizure disorders.\n19. Life-threatening allergies, hypersensitivity, or documented intolerance to TRX319 drug product excipients.\n20. Subjects that are pregnant, breast feeding or aim to become pregnant during the study period (Subjects must agree to use a highly effective method of contraception).\n21. Serious and\u002For uncontrolled medical condition that, in the Investigator's judgment, would cause unacceptable safety risk, interfere with study procedures or results, or compromise compliance with the protocol.","ALL","18 Years","65 Years",{"count":21,"type":22},39,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","The goal of this clinical trial is to treat male and female participants with two types of Multiple Sclerosis (MS) called primary progressive or secondary progressive MS.\n\nThe main questions the trial aims to answer are the following:\n\n* Is TRX319 safe when administered to patients with progressive forms of MS?\n* At what dose does TRX319 work the best to treat participants with primary and or secondary progressive MS?\n* Is pre-conditioning (with Bendamustine) needed to allow TRX319 to better treat participants with primary and\u002For secondary progressive MS?\n\nParticipants will be asked to be on study for up 1 year and may receive up to 3 total administrations of TRX319. While on study, participants will have blood tests and other assessments (MRI scans and lumbar punctures) done to understand the safety of TRX319 and how it may benefit their multiple sclerosis.",[29,30,31,32,33],"Primary Progressive Multiple Sclerosis","Secondary Progressive Multiple Sclerosis (SPMS)","Multiple Sclerosis","Multiple Sclerosis (MS) Primary Progressive","Multiple Sclerosis (MS) Secondary Progressive",[35,15,36,31,37,38,39,40,41,42,43],"TRX319-01","Tr1X","MS","Autoimmune","Impact MS","PPMS","SPMS","Primary Progressive","Secondary Progressive","RECRUITING","2026-03-17",{"date":47,"type":48},"2026-03-19","ACTUAL",{"date":50,"type":22},"2026-03",{"date":52,"type":22},"2029-01",{"name":54,"class":55},"Tr1X, Inc.","INDUSTRY",2,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":64,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100571569","phase-1-treatment-of-moderate-to-severe-refractory-crohns-disease-100571569","NCT06721962","Treatment of Moderate to Severe Refractory Crohn's Disease","A Phase 1\u002F2a, Open Label, Dose Escalation Study to Evaluate the Safety and Preliminary Efficacy of TRX103 in Subjects With Moderate to Severe Treatment-Refractory Crohn's Disease","Inclusion Criteria:\n\n1. Male and females ≥ 18 and ≤ 65 years of age at time of consent.\n2. Weight of ≥ 40 kg.\n3. Medical history and biological evidence of active bowel inflammation documented by:\n\n   * Minimum of approximate 1 year of Crohn's disease diagnosis confirmed through Endoscopy, and;\n   * Endoscopic evidence of CD diagnosis at least 3 months prior to and\u002For at Screening (SES-CD ≥ 6 for ilealcolonic or ≥ 4 isolated ileal disease by central reader)\n4. Active disease defined as moderate to severe active CD at Screening defined by all of the following:\n\n   * Evidence of mucosal inflammation, defined as SES-CD ≥ 6 (≥ 4 for subjects with isolated ileal disease), and;\n   * CDAI total scores ≥ 220\n5. Subject on treatment with corticosteroids may be included if they meet the following:\n\n   * prednisone or equivalent dose ≤ 20 mg\u002Fday; or\n   * budesonide ≤ 9 mg\u002Fday; or\n   * has been on a stable dose for at least 7 days prior to TRX103 dose.\n6. Advanced therapy-refractory disease defined by:\n\n   Failure of two or more advanced approved therapies. Prior therapies may be inclusive of any combination of the following:\n   * TNF-alpha inhibitors\n   * IL-12\u002F23 inhibitors\n   * Anti-integrins\n   * JAK inhibitors Failure of therapies are defined as either non-response (primary failure), complete loss of response (secondary failure) or intolerant to therapy at a dose indicated for CD.\n   * Primary failure is defined as:\n\n     * When a subject does not achieve a response after having received the induction doses of a CD approved drug per prescribing information. Induction period is defined as 12-weeks.\n     * A response is defined as CDAI score that reduces by ≥ 100-point from Baseline or by Physician assessment.\n   * Secondary failure, or relapse defined as:\n\n     * Subjects who respond to the therapy or achieves remission after an induction regimen per prescribing information, but subsequently lose response or relapses during maintenance treatment.\n     * Relapse is defined as an increase in the CDAI score from maintenance of ≥ 100 points and a CDAI score \\> 220, and\u002For SES-CD score ≥ 6 (or ≥ 4 if isolated ileal disease) or by Physician assessment.\n   * Intolerant to therapy, defined as:\n\n     * When a subject is unable to cope with the side effects or mechanism of actions of the treatment and\u002For experiences unacceptable side effects when dosed at appropriate therapeutic levels.\n7. Absence of uncontrolled bacterial, viral, or fungal infection at time of enrollment.\n8. Subjects must be able to understand and sign informed consent and be willing and able to complete all specified procedures and visits.\n\nExclusion Criteria:\n\n1. Prior organ transplant, or allogeneic bone marrow, peripheral blood, or cord blood stem cell transplant. Note: Blood transfusion are not exclusionary if it occurred ≥ 3 years (- 3 months) of TRX103 infusion.\n2. Received another investigational agent or therapy, within 28 days of planned TRX103 infusion (or 5 half-lives, whichever is longer) and\u002For have not recovered from treatment related toxicities.\n3. Received any approved treatment for CD within the designated washout period (including off-label use of approved therapies) as per the protocol.\n4. Strictures, active fistulae (including perianal), or abscess by computed tomography (CT) or magnetic resonance enterography (MRE) or Endoscopy within 6 months of Screening.\n5. Positive serology for HIV.\n6. Positive hepatitis-B surface antigen. Subject may be included if they are HBV PCR negative.\n7. Hepatitis C virus (HCV RNA detectable in any subject with anti-HCV antibodies).\n8. Subject with active or chronic recurring infections or untreated latent Tuberculosis (TB).\n9. Current diagnosis of ulcerative colitis (UC), indeterminate colitis or CD isolated to colon only (the colitis must be related to CD and inclusive of ileal with or without colonic involvement).\n10. Subjects with the following known complications of Crohn's Disease\n\n    * active diverticulitis,\n    * active fistulae or abscess,\n    * abscess (abdominal or perianal) - abscess with no evidence of pus when pressed upon are permitted,\n    * impassable fibrotic strictures - Patients with strictures passable by dilation are permitted,\n    * symptomatic bowel strictures - must be confirmed via endoscopy and\u002For radiologically,\n    * fulminant colitis,\n    * toxic megacolon,\n    * ostomy or ileoanal pouch - previous temporary ostomy pouch, followed by a reversal is permitted,\n    * diagnosed with short gut or short bowel syndrome,\n    * or any other manifestation that might require surgery while enrolled in the study.\n11. Subject with surgical bowel resection within the past 3 months prior to Screening, or a history of \\> 2 bowel resections. Note: Surgery for temporary use of an ostomy bag or reconnection of the gut post colostomy use is not considered exclusionary, nor considered as part of the surgical resection if during the reconnection removal of tissue is required to facilitate reattachment.\n12. Subjects that are pregnant, breast feeding, or aim to become pregnant during the 12 month study period. (Subjects, males and females, must agree to use a highly effective method of contraception).\n13. Screening laboratory and other analyses show any of the following abnormal results:\n\n    * Serum aspartate transaminase or alanine transaminase \\> 3.0 × upper limit of normal;\n    * Total white blood cell count \\\u003C 2,000\u002FμL;\n    * Estimated glomerular filtration rate by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula or by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation \\\u003C 40 mL\u002Fmin\u002F1.73 m2;\n    * Hemoglobin \\\u003C 8 g\u002FdL;\n    * Bilirubin ≥ 2 x ULN;\n    * Platelet count \\\u003C 100,000\u002FμL;\n    * Absolute neutrophil count \\\u003C 1,200\u002FμL;\n    * Absolute lymphocytes count \\\u003C 750\u002FμL.\n14. Any subject with a history of significant renal, hepatic, pulmonary, or cardiac dysfunction, or on treatment to support cardiac dysfunction.\n15. Any serious illness, uncontrolled inter-current illness, psychiatric illness, active or uncontrolled infection, or other medical condition or history, including laboratory results, which, in the Investigator's opinion:\n\n    * places the subject at increased risk during participation in the study, and\u002For;\n    * interferes with the subject's capacity to provide informed consent and their participation in the study, and\u002For;\n    * interferes with the interpretation of the results.",{"count":21,"type":22},[25,26],"This research study is testing an investigational research product called TRX103 as a possible treatment for individuals suffering from Crohn's Disease (CD). The primary purpose of this study is to learn how safe and effective different doses of TRX103 are when administered to individuals with CD.",[68],"Crohns Disease",[36,70,71,68,72,73,74,75,76,77,78,79],"RESTORE","Crohns","autoimmune","IBD","CD","chronic inflammation","gastrointestinal tract","chronic diarrhea","intestinal ulcers","abdominal pain","2025-12-03",{"date":82,"type":48},"2025-12-10",{"date":84,"type":48},"2025-05-05",{"date":86,"type":22},"2027-01-30",{"name":54,"class":55},13,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":99,"conditions":100,"keywords":112,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},"100551613","phase-1-prevention-of-gvhd-in-participants-with-hematological-malignancies-undergoing-hematopoietic-stem-cell-transplant-hsct-100551613","NCT06462365","Prevention of GvHD in Participants With Hematological Malignancies Undergoing Hematopoietic Stem Cell Transplant (HSCT)","Phase I, First in Human, Open Label Study to Evaluate Safety and Tolerability of TRX103 Cells in Subjects With Hematological Malignancies Undergoing HLA-mismatched Related or Unrelated Hematopoietic Stem Cell Transplantation (HSCT)","Inclusion Criteria:\n\n1. Subjects with one of the following hematologic malignancies: Acute Lymphoblastic Leukemia (B- or T-ALL), Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), or Chronic myelomonocytic leukemia (CMML)\n2. Males and Females Age ≥ 18 years.\n3. Weight of ≥ 35 Kg.\n4. Karnofsky performance status ≥ 70 %.\n5. Available mismatched related (haploidentical) or unrelated donors for peripheral blood stem cell (PBSC) donation.\n6. Subjects must otherwise fulfill institutional criteria for eligibility to undergo allogeneic stem cell transplantation.\n7. Absence of uncontrolled bacterial, viral or fungal infection at time of enrollment.\n8. Have adequate organ function.\n9. Subjects \\> 65-year-old receiving MAC conditioning will only be eligible if they have a HSCT-comorbidity index score \\\u003C 5.\n10. Subjects must be able to understand and sign informed consent and be willing and able to complete all specified procedures and visits.\n\nExclusion Criteria:\n\n1. Prior allogeneic bone marrow, peripheral blood, or cord blood HSCT.\n2. Any subject with a history of significant renal, hepatic, pulmonary, or cardiac dysfunction, or on treatment to support cardiac dysfunction.\n3. HIV positive.\n4. Positive hepatitis-B surface antigen. Subject may be included if they are HBV PCR negative.\n5. Positive hepatitis-C antibody with positive Recombinant Immunoblot Assay (RIBA) or PCR unless the subject has received curative anti-viral treatment and confirmed negative viral load by PCR.\n6. Received another investigational agent for treatment of disease understudy within 28 days (or 5 half-lives, whichever is shorter) of conditioning and\u002For have not recovered from treatment related toxicities.\n7. Subjects with a previous history of Thrombotic Thrombocytopenic Purpura (TTP) or Hemolytic Uremic Syndrome (HUS) who are not good candidates for treatment with sirolimus.\n8. Subjects that are pregnant, breast feeding or aim to become pregnant during the study period. (Subjects must agree to use a highly effective method of contraception).\n9. Any serious illness, uncontrolled inter-current illness, psychiatric illness, active or uncontrolled infection, or other medical condition or history, including laboratory results.",{"count":97,"type":22},36,[25],"The purpose of this Phase 1, first in human open-label study is to assess the safety and tolerability of TRX-103 in patients with hematological malignancies undergoing HLA-mismatched related or unrelated hematopoietic stem cell transplantation (HSCT). It is anticipated that up to 36 Subjects will be enrolled during a 18-24 month enrollment period. TRX-103 will be infused one time post HSCT.",[101,102,103,104,105,106,107,108,109,110,111],"Hematologic Malignancy","GvHD","GVHD,Acute","GVHD, Chronic","Hematopoietic Stem Cell Transplant","Acute Lymphoblastic Leukemia, Adult B-Cell","Acute Lymphoblastic Leukemia, Adult T-Cell","Acute Myeloid Leukemia in Remission","Myelodysplastic Syndromes","Chronic Myelomonocytic Leukemia, in Remission","Cancer Remission",[113,114,115,116,117,118,119,120,121,122,38,123],"AML","CMML","Stem Cell Transplant","B-ALL","T-ALL","Acute GvHD","Graft versus Host Disease","Chronic GvHD","MDS","Cellular Therapy","T regulatory cells","2025-04-10",{"date":126,"type":48},"2025-04-15",{"date":128,"type":48},"2024-04-08",{"date":130,"type":22},"2027-04-15",{"name":54,"class":55},5,""]